BOSTON - More than three decades after the identification of the human immunodeficiency virus (HIV), scientists are still working to develop a preventative vaccine that could finally put an end to the epidemic for which there are nearly two million new infections each year.

In a new study, published July 6 in The Lancet, a team of researchers led by Beth Israel Deaconess Medical Center's Dan H. Barouch, MD, PhD, Director of the Center for Virology and Vaccine Research in collaboration with Janssen Vaccines & Prevention and other partners, evaluated a series of preventative HIV vaccine regimens in uninfected human volunteers in five countries. In a similarly designed study, Barouch and colleagues tested the same vaccine for its ability to protect rhesus monkeys challenged with an HIV-like virus from infection. The findings showed the vaccines induced robust and comparable immune responses in humans and monkeys and protected monkeys against acquisition of infection.

"This study demonstrates that the mosaic Ad26/Ad26 plus gp140 vaccine candidate induced robust and comparable immune responses in human and monkeys," said Barouch, who is also Professor of Medicine at Harvard Medical School. "Moreover, the vaccine provided 67 percent protection against viral challenge in monkeys."

Intended to provide broad protection from the many strains of HIV that are prevalent worldwide, the "mosaic" vaccine contains a patchwork of genetic sequences found among various HIV strains. Known as APPROACH, the phase 1/2a trial tested seven different Ad26/Env HIV vaccine regimens for their safety, tolerability and the ability to elicit immune responses in 393 healthy adult volunteers in Rwanda, South Africa, Thailand, Uganda and the United States. All vaccine regimens were well-tolerated and induced robust immune responses in the participants.

"Based on these data, the mosaic Ad26/Env HIV-1 vaccine has been advanced into a phase 2b clinical efficacy study to determine whether this vaccine will prevent HIV infection in humans in southern Africa," said Barouch. "We expect results in 2021. This is only the 5th HIV vaccine concept that will be tested for efficacy in humans in the 35+ year history of the global HIV epidemic."

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The study is the result of a collaboration among researchers at BIDMC, Harvard Medical School and the Ragon Institute of Massachusetts General Hospital, MIT and Harvard; the United States Military HIV Research Program (MHRP) at the Walter Reed Army Institute of Research (WRAIR); the National Institute of Allergy and Infectious Diseases (NIAID); the International AIDS Vaccine Initiative; the HIV Vaccine Trials Network (HVTN), Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson; and multiple other partners.

This study was funded by Janssen Vaccines & Prevention BV and the National Institutes of Health (OD024917, AI068618, AI078526, AI096040, AI124377, AI126603, AI128751, TR001102), the Ragon Institute of MGH, MIT and Harvard, and a cooperative agreement (W81XWH-07-2-0067) between the Henry M Jackson Foundation for the Advancement of Military Medicine and the US Department of Defense. The opinions or assertions contained herein are the private views of the authors, and are not to be construed as official, or as reflecting true views of the Department of the Army or the US Department of Defense. Medical writing support was provided by Katie Holmes (Zoetic Science), and was funded by Janssen Pharmaceuticals. We thank the International AIDS Vaccine Initiative (IAVI) and the generous support of USAID and other donors; a full list of IAVI donors is available online.

About Beth Israel Deaconess Medical Center

Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School and consistently ranks as a national leader among independent hospitals in National Institutes of Health funding.

BIDMC is in the community with Beth Israel Deaconess Hospital-Milton, Beth Israel Deaconess Hospital-Needham, Beth Israel Deaconess Hospital-Plymouth, Anna Jaques Hospital, Cambridge Health Alliance, Lawrence General Hospital, MetroWest Medical Center, Signature Healthcare, Beth Israel Deaconess HealthCare, Community Care Alliance and Atrius Health. BIDMC is also clinically affiliated with the Joslin Diabetes Center and Hebrew Rehabilitation Center and is a research partner of Dana-Farber/Harvard Cancer Center and the Jackson Laboratory. BIDMC is the official hospital of the Boston Red Sox. For more information, visit http://www.bidmc.org.

The Lancet HIV: New HIV infections stagnating at 2.5 million a year worldwideA major new analysis from the Global Burden of Disease 2015 study, published today in The Lancet HIV journal, reveals that although deaths from HIV/AIDS have been steadily declining from a peak in 2005, 2.5 million people worldwide became newly infected with HIV in 2015, a number that hasn't changed substantially in the past 10 years.

Study examines risk of HIV transmission from condomless sex with virologically suppressed HIV infectionAmong nearly 900 serodifferent (one partner is HIV-positive, one is HIV-negative) heterosexual and men who have sex with men couples in which the HIV-positive partner was using suppressive antiretroviral therapy and who reported condomless sex, during a median follow-up of 1.3 years per couple, there were no documented cases of within-couple HIV transmission, according to a study appearing in the July 12 issue of JAMA, an HIV/AIDS theme issue.

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